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Date: 11.01.2012
From: Richmond Pharmacology

Subject: Would you be interested in taking part in a trial of patients with Rheumatoid Arthritis?

Richmond Pharmacology conducts medical research to help develop new medicines. Our 2 research units, based in London at St Georgeās University Hospital and Croydon University Hospital, provide you with the safest and most comfortable facilities. Richmond Pharmacology works closely with Hospital Consultants, Research Physicians, and Clinicians ensuring the research we conduct is meaningful, ethical, and safe.

What is this all about?

Chronic inflammation is most appropriately defined in terms of the process, in which continuing inflammation and attempted tissue healing by repair occur simultaneously. Chronic inflammation results in a variety of diseases, depending on the location of and trigger for the inflammation. These diseases include asthma, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis (RA) and psoriasis but there are many other diseases and disorders caused by chronic inflammation.

Richmond Pharmacology is conducting a clinical trial for a new experimental drug called FX125L. FX125L is an anti-inflammatory agent being developed for the treatment of chronic inflammatory diseases such as asthma, COPD, RA and psoriasis. It is anticipated that FX125L may be more effective and have fewer side effects compared to the current marketed drugs.

This is the first time FX125L will be given to patients with chronic inflammation. The purpose of this study, therefore, is to examine the impact of treatment with such an agent in patients with a range of different diseases that share a chronic inflammatory component. The purpose of this study is also to collect information on markers which will help us to plan future research studies, to further test the effect of this compound.

The trial is being conducted at Richmond Pharmacology Ltd only.

To qualify for participation in this study you need to:

* Be aged between 18 and 77 years (inclusive) at screening

* Have a documented diagnosis of Rheumatoid Arthritis (with a confirmed medical history available from your GP).

* Stable disease for at least 1 month prior to Screening and have not used any steroids to treat your disease during this time.


* Have at least 6 swollen and 6 tender joints.

* Have a body mass index (BMI) between ≥18.0 and ≤35.0 kg/m2 (inclusive). Your BMI is calculated using the formula: weight (in kilograms) divided by height (in metres) squared).

If the above sounds like this is you then read on:

What will happen?

This study is being conducted at our research facility at Croydon University Hospital in London. If you are interested in taking part you will need to contact us to register your interest.
If you successfully pass the telephone screening you will be invited to our facility where you will undergo a screening examination. This is vital to ensure it is safe for you to take part in the trial. You will be required to attend a screening visit 14 to 28 days before the start of the study. If you pass the screening visit you will be invited to take part in the study.

Study Participation

Participation for this study requires you to attend 5 out-patient visits and one residential stay of 1 night and 1 day at our clinical unit at Croydon University Hospital. This includes the screening visit (Visit 1) within 14 to 28 days before the start of the study, one residential stay of 1 night/1 day at our unit (Visit 2), 3 outpatient visits on Days 10, 42 and Day 56 (Visits 3, 4 and 5) and the final follow up visit (Visit 6) after the last dose of the study drug. Your participation in this study will last approximately 17 weeks.

For an example of a study timetable please go to:

Please Note: There are groups starting on a weekly basis so call us and we will find one that fits with your schedule

What's in it for you?

Apart from doing something good, we will also compensate you for your time in the form of a monetary payment.

You will receive £560 your time on completion of the study, once follow-up results are confirmed, checked and deemed complete by the study doctor. You will be paid an additional bonus of £280 subject to your satisfactory compliance with the documents provided before study commencement (Volunteer Information sheet and Informed Consent, the Richmond Pharmacology Volunteer Charter and all other unit regulations).

The total amount that you could be paid for study participation is £840. You will also be compensated for your travel expenses.*

* You will receive travel expenses up to a value of £150 if you are included in the study and following the delivery of valid receipts for travel relating to your participation in this study. All study related travel expenses within the limit of £150 will be paid in conjunction with your study payment following the completion of your participation in the trial.

Want to find out more?

If you are interested in finding out more select the I am interested link below to receive a call back from one of our team


Call us free on 0208 664 5200 and choose option 1 and speak to a member of our Volunteer Recruitment Team.
A detailed information sheet is available on request.

On behalf of the
Richmond Pharmacology Volunteer Recruitment Team

Ref: FXT_Oct 2011
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Date: 19.01.2012
From: Mrs Sheila Young

Subject: Re: Would you be interested in taking part in a trial of patients with Rheumatoid Arthritis?

Hello,I am taking METHOTREXATE for about 10 years which gives some relief, but locally in Leicester there is no alternative available except doubling the dose which is not tolerable by me ,and wondered why Patients taking that are unsuitable, thanks Sheila Young
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Date: 20.01.2012
From: Richmond Pharmacology

Subject: Re: Would you be interested in taking part in a trial of patients with Rheumatoid Arthritis?

Dear Sheila,

Thank you for your message. The reason why patients can't be on METHOTREXATE is because it is a disease modifying drug that affects the immune system and as such will interfere with the study drug being tested (FX125L), which is thought to be more effective and have fewer side effects. I hope that answers your question, if you happen to come off of METHOTREXATE and have an interest in take part in this trial you can email any questions to It will be ongoing through to July this year. Regards - On behalf of the Richmond Pharmacology Volunteer Recruitment Team.
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Date: 21.01.2012
From: kylee

Subject: Re: Would you be interested in taking part in a trial of patients with Rheumatoid Arthritis?

would that be the same for people on enbrel injections
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Date: 24.01.2012
From: Richmond Pharmacology

Subject: Re: Would you be interested in taking part in a trial of patients with Rheumatoid Arthritis?

Dear Kylee,

Unfortunately yes, the use of enbrel injections or any other biological anti-inflammatory therapy within 6 months of screening would rule out participation in the trial.

Sheila: adding to your question on methotrexate, in the event that 10 RA patients have not been enrolled onto the study within 3
months of the study start, the Sponsor may elect to alter the exclusion criteria for RA patients such that patients on a stable dose of methotrexate(7.5 to 25 mg/week for a minimum of 1 month prior to study randomization) may be included in the study.

Regards, RPL
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